Recall Z-1604-2015— HeartWare Inc
Class I · Ongoing
Class I FDA medical device recall by HeartWare Inc, initiated 2015-04-29. FDA's recall record names no specific 510(k) clearance for this event. Product: HeartWare Ventricular Assist System (HVAD) Pump Driveline Splice Kit Product Usage: Is intended to repair the driveline cable once an electrical break has been identified. These repairs are limited to the portion of the driveline that is outside the patient boundary (exit side).. Reason: Failures of the splice repair kit if exposed to excessive force..
- Recalling firm
- HeartWare Inc
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2015-04-29
- Firm location
- Miami Lakes, FL, United States
Product description
HeartWare Ventricular Assist System (HVAD) Pump Driveline Splice Kit Product Usage: Is intended to repair the driveline cable once an electrical break has been identified. These repairs are limited to the portion of the driveline that is outside the patient boundary (exit side).
Reason for recall
Failures of the splice repair kit if exposed to excessive force.
Data sourced from openFDA. This site is unofficial and independent of the FDA.